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510(k) Data Aggregation

    K Number
    K241958
    Device Name
    WARD-CSS (v1.2.x)
    Manufacturer
    WARD 24/7 ApS
    Date Cleared
    2025-02-14

    (226 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WARD 24/7 ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WARD-CSS is a clinical decision support system that remotely integrates, analyzes and displays continuous vital sign data (via a mobile or web application) from medical devices for nonpediatric hospitalized patients within non-critical care units. WARD-CSS uses a set of standardized rules based on scientific and clinical evidence to detect and alert on clinically relevant vital sign deviations when used by trained health care professionals in hospitals. WARD-CSS is not intended to replace current monitoring practices or replace health care professionals' judgment. WARD-CSS is a tool intended to help health care professionals manage monitored patients and make clinical care decisions.
    Device Description
    WARD-CSS is a stand-alone software intended for use in continuous monitoring of patients and near real-time analysis of vital signs for the purpose of notifying healthcare professionals in case of clinically relevant vital sign deviations. WARD-CSS utilizes knowledge-based algorithms to evaluate clinically relevant vital signs deviations to help drive clinical management. The system is intended to be used as an adjunct to current monitoring practice in the general med/surg floors of the hospitals The system assists healthcare professionals when monitoring patients on their wards by: - Providing a real-time monitoring overview of vital signs for all patients. ● - Alerting the healthcare professionals when a patient deteriorates. ● The following types of alerts are detected by WARD-CSS in the vital sign data: - Desaturation ● - Hypertension - Hypotension ● - Bradypnea ● - Tachypnea ● - Tachycardia - Bradycardia - Hypotension and Bradycardia - Hypotension and Tachycardia ● - Bradypnea and Desaturation - Fever The WARD-CSS consists of a Mobile App, Web App and Backend Server. The Mobile App is used by healthcare professionals (HCPs) to monitor patients. The HCP will receive notifications of the alerts to their mobile phones. Within this app, the HCP can also document vital signs into an electronic health record system. The Web App is used by administrative users to manage hospitals, wards, users, and monitors. The Backend Server is used to receive and process all incoming data and manage all data used in the apps.
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